StrokeNCT02842840
The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients
A study testing Patient-based intervention, Family based intervention and Routine counseling in people with Stroke and Medication Adherence, run by Qazvin University Of Medical Sciences at 3 sites in Iran.
Trial summary
Stroke is a major cause of morbidity and mortality, especially in low and middle income countries including Iran. Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Medication Adherence, Older Adults
- What is being tested?
- Patient-based intervention, Family based intervention and Routine counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 3 sitesIran
- Study dates
- Apr 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65 years or older
- able to give informed consent
Who cannot join
- recurrent stroke
- a diagnosis of subarachnoid haemorrhage
- significant impairments precluding participation - inability to give informed consent
- another condition likely to impact their participation in the trial (e.g. life-threatening condition other than cardiovascular disease)
- expected discharge to hospital/nursing home setting
Trial locations and contacts
3 sites in 1 country.
Iran3 sites, 3 recruiting
- Recruiting
Department of Public Health, Qazvin University of Medical Sciences
Qazvin, Qazvin Province, 3419759811
Amir Pakpour, Ph.D., 982813338127, amir.pakpour@gmail.com
Amir H Pakpour, Ph.D.
- Recruiting
Qazvin University of Medical Sciences
Qazvin, Qazvin Province, 3419759811
Amir H Pakpour, PhD, 982813338127, Pakpour_Amir@yahoo.com
- Recruiting
Outpatient Pediatric Clinic
Qazvin, Qazvin Province
Amir H Pakpour, PhD, 982813338127, amir.pakpour@gmail.com
About this study
Official title: The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients: A Randomised Trial
Stroke is a major cause of morbidity and mortality, especially in low and middle income countries including Iran. Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. The study is aimed to evaluate an intervention to improve patients with Stroke.
- Conditions
- Stroke, Medication Adherence, Older Adults
- Being tested
- Patient-based intervention, Family based intervention, Routine counseling
- Medical subject headings
- Stroke, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-based interventionBehavioural
Family based interventionBehavioural
Routine counselingOther
| Study group | Role | What they receive |
|---|---|---|
| Patients based intervention | Experimental | A multifaceted intervention program will use to improve adherence and clinical outcomes in Stroke patients. This intervention focus on behavioral treatment in the patients. Receives: Behavioral: Patient-based intervention |
| Family based intervention | Experimental | Patients and their families will receive a series of educational/motivational interventions. Receives: Behavioral: Family based intervention |
| Routine counseling | Active comparator | All participants of the study in both group receive the Standard Care. Usually, patients in clinics receive a one-time session of brief advice to use medications regularly lasting approximately 30 minutes and deliver by nurse or physician. Some issues rise in this short session including coexisting diseases, the history of drug use, current disease and advice about the health risks of irregular medication use. Receives: Other: Routine counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Patient-reported Adherence Medication Adherence Rating Scale
a self-report measure of adherence (Medication Adherence Report Scale [MARS-5]) will be used .
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes in blood pressure
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes in low-density lipoprotein (LDL)-cholesterol level
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
Secondary outcomes (7)
Changes in intention to medication adherence
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Action Plan
The action plan is assessed by a self-reported questionnaire. it is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Coping Plan
The coping plan is assessed by a self-reported questionnaire. It is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in quality of life
The Short Form (36) Health Survey is used to assess patient's quality of life
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in perceived behavioral control to medication adherence
The perceived behavioral control to medication adherence is assessed through a self-report instrument
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Self-monitoring to medication adherence
The Self-monitoring to medication adherence is assessed through a self-report instrument
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Illness Perceptions
the Brief Illness Perception. Questionnaire (Brief IPQ) is used to assess patient's illness representation
Measured: changes from baseline, 6 Months, 12 months and 18 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842840
- Sponsor's protocol ID
- IR.QUMS.REC.1394.350
- Status last verified
- Jul 2016
- First submitted
- 12 Apr 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients: A Randomised Trial
- ClinicalTrials.gov ID
- NCT02842840
- Acronym / sponsor ID
- IR.QUMS.REC.1394.350
- Conditions
- Stroke, Medication Adherence, Older Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is a major cause of morbidity and mortality, especially in low and middle income countries including Iran. Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. The study is aimed to evaluate an intervention to improve patients with Stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients based intervention | Experimental | Behavioral: Patient-based interventionA multifaceted intervention program will use to improve adherence and clinical outcomes in Stroke patients. This intervention focus on behavioral treatment in the patients. |
| Family based intervention | Experimental | Behavioral: Family based interventionPatients and their families will receive a series of educational/motivational interventions. |
| Routine counseling | Active comparator | Other: Routine counselingAll participants of the study in both group receive the Standard Care. Usually, patients in clinics receive a one-time session of brief advice to use medications regularly lasting approximately 30 minutes and deliver by nurse or physician. Some issues rise in this short session including coexisting diseases, the history of drug use, current disease and advice about the health risks of irregular medication use. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- aged 65 years or older
- able to give informed consent
Key exclusion criteria (5 listed)
- recurrent stroke
- a diagnosis of subarachnoid haemorrhage
- significant impairments precluding participation - inability to give informed consent
- another condition likely to impact their participation in the trial (e.g. life-threatening condition other than cardiovascular disease)
- expected discharge to hospital/nursing home setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-based intervention | Behavioural | Patients based intervention |
| Family based intervention | Behavioural | Family based intervention |
| Routine counseling | Other | Routine counseling |
Primary outcome
changes in Patient-reported Adherence Medication Adherence Rating Scale
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
a self-report measure of adherence (Medication Adherence Report Scale [MARS-5]) will be used .
changes in blood pressure
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes in low-density lipoprotein (LDL)-cholesterol level
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
7 secondary outcomes
Changes in intention to medication adherence
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Action Plan
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Coping Plan
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in quality of life
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in perceived behavioral control to medication adherence
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Self-monitoring to medication adherence
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Illness Perceptions
Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Public Health, Qazvin University of Medical Sciences
Qazvin, Iran
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-based intervention, Family based intervention and Routine counseling in people with Stroke and Medication Adherence, run by Qazvin University Of Medical Sciences at 3 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Patient-reported Adherence Medication Adherence Rating Scale (time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.